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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K230502
Device Name Ear Pressure Relief Device(Model:ER813B)
Applicant
Ningbo Albert Novosino Co., Ltd.
# 28 Yunshan Middle Rd., Sanqishi Town
Yuyao,  CN 315412
Applicant Contact Victor Zhou
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Classification Product Code
MJV  
Date Received02/24/2023
Decision Date 06/09/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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